The invention relates to a medical device and, more particularly, to a lasing device for performing a myringotomy.
Otitis media is the medical term for an infection of the middle ear, which is characterized by the build-up of fluid and pressure, causing significant pain in the ear. Otitis media occurs in adults, and more frequently in children, and seems to reoccur often in particular individuals. In the United States, otitis media in children results in an estimated 25 million physician office visits each year, representing 40% of all pediatric office visits, and the insertion of more than one million ear drainage tubes annually. In all, the overall cost of treating otitis media in the United States is approximately five billion dollars per year.
The treatment for otitis media currently involves the use of an antibiotic, such as amoxicillin, coupled with the use of a needle, lancet or blade which is used to puncture the ear drum or make an incision therein, to allow fluid to escape and the middle ear to aerate, i.e., a procedure commonly referred to as a myringotomy. This procedure frequently requires hospitalization and general anesthesia in children. However, because mechanical punctures have a tendency to heal and close in a few days, the buildup of fluid reoccurs and the pain caused by the pressure returns. To allow for continued drainage, the treatment for otitis media also currently involves the insertion of a tiny tympanotomy or drainage tube through the puncture to keep the puncture open and permit the continued flow of fluid and aeration of the surrounding ear drum area for a two to five week period. The tube is typically removed in a second visit to the physician. If the tube becomes clogged or falls out prematurely, another visit to the physician is required to clear or reinsert the tube, which necessarily increases the cost of treating the infection.
While a myringotomy can be performed by a general practitioner, family practitioner or pediatrician, it is often performed by an otorhinolaryngologist (ear, nose and throat specialist), which necessarily entails the incurment of substantial professional fees.
Thus, there remains a need for a device which can be used in a medical office by a family or general practitioner or pediatrician to create a puncture, which will remain open and will not require the insertion of a separate tube, eliminating the need for a second office visit. There is also a need for a device which will create a puncture in a matter of a few seconds without any hospitalization or general anesthesia. Still further, there is a need for a device which does not need to be sterilized prior to or after performing the myringotomy procedure.
The present invention contemplates a lasing device adapted to create a long lasting (two to five week) puncture in the ear drum for treating otitis media and other like middle ear infections, and eliminating the need for hospitalization, general anesthesia, repeat office visits and the sterilization of the laser device prior to or after use.
The lasing device comprises a laser energy conduit, such as a fiber optic, with a proximal end adapted for coupling to a laser energy source and a distal end portion covered by a removable sheath whose distal end is substantially transparent to the laser energy being emitted through the distal end of the conduit.
In one embodiment, a pocket in the distal end portion of the sheath receives a lens which diverges the beam of laser energy emitted from the conduit.
In another embodiment, the sheath includes a body portion that terminates in a cap integrally connected to the body portion and transparent to the laser energy emitted through the conduit.
In yet another embodiment, the sheath includes an inner surface which defines an opening in the distal end portion thereof and a film cap which covers the opening; the film insert is transparent to the laser energy being emitted through the conduit.
In a preferred embodiment, the sheath includes a heat-shrinkable plastic whose distal end is heat shrunk over a relatively short cylinder of quartz or fused silica. The distal end surface of the cylinder can be sandblasted and/or carbon coated, if desired. One aspect of the present invention is directed to a mounting structure for the sheath to the conduit. In one specific embodiment, ribs on the inner surface of the sheath create a friction engagement with the outer surface of the conduit. In another embodiment, the conduit outer surface and the sheath inner surface define a plurality of spaced-apart, complementary and flexible ribs which coact to hold the sheath over the conduit and portion during use. In another embodiment, the ribs are located on the conduit and abut against the inner surface of the sheath. In yet another embodiment, the ribs on the conduit are received in grooves in the inner surface of the sheath.
Other features and advantages of the present invention will become readily apparent from the following detailed description, the appended drawings, and the accompanying claims.